STABILITY INDICATING SIMULTANEOUS ESTIMATION OF METFORMIN AND EMPAGLIFLOZIN IN PHARMACEUTICAL TABLET DOSAGE FORM BY RP-HPLC

A simple, rapid, accurate, precise, specific, sensitive and stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of Metformin and Empagliflozin in bulk drug and pharmaceutical dosage form. The chromatographic separation was performed on the Kromasil C₁₈ column (250mm×4.6mm, 5μm particle size), using a mobile phase of buffer: Acetonitrile taken in the ratio 45:55 v/v, at a flow rate of 1.1 ml/min at an ambient temperature of 30˚C with the detection wavelength at 226nm. The retention times of Metformin and Empagliflozin were 2.182 min and 2.908 min, respectively. The linearity was performed in the concentration range of 125-750 ppm, 3.12-18.75 ppm each of Metformin and Empagliflozin with a correlation coefficient of 0.999 and 0.999 for Metformin and Empagliflozin respectively. The percentage purity of Metformin and Empagliflozin was found to be 100.59% and 100.07% respectively. The proposed method has been validated for specificity, linearity, range, accuracy, precision, and robustness were within the acceptance limit according to ICH Q2 (R1) guidelines, and the developed method can be employed for routine quality control analysis in bulk and combined pharmaceutical dosage form of Metformin and Empagliflozin.